Senior Aseptic Operator

Job Title: Senior Aseptic Operator

Job Overview: 

Our organization, a leader in contract manufacturing for sterile pharmaceuticals and biologics, is seeking a highly skilled Senior Operator with expertise in sterile manufacturing process controls and industrial automation. This critical role supports GMP manufacturing operations, ensuring high-quality production of pharmaceutical and biologic products. The ideal candidate will bring hands-on experience in GMP environments, aseptic processing, and equipment operation to maintain robust, compliant, and efficient manufacturing processes. The Senior Operator will collaborate with cross-functional teams, contribute to process optimization, and train others to support operational excellence.

Job Responsibilities:

• Execute manufacturing and production procedures in compliance with GMP standards.
• Perform tasks in Grade C, D, and controlled non-classified cleanroom environments.
• Conduct aseptic manipulations within Grade A isolators with precision and adherence to protocols.
• Carry out cleaning, sanitization, equipment preparation, and aseptic filling activities as required.
• Operate production equipment safely, including setup, changeovers, and routine maintenance.
• Accurately document process data and complete batch records to ensure compliance.
• Support the execution of validation and engineering protocols as needed.
• Train team members on manufacturing tasks, including fill/finish, sanitization, and equipment preparation.
• Troubleshoot equipment issues and perform maintenance to ensure operational continuity.
• Contribute to equipment optimization and continuous improvement initiatives.
• Collaborate with cross-functional teams to support production goals and resolve issues.
• Work flexible hours to ensure coverage and continuity of manufacturing operations.

Qualifications:

• High School diploma required, with at least 3 years of GMP pharmaceutical experience in the operation, cleaning, and maintenance of aseptic filling equipment.
• Working knowledge of Microsoft Office (Word, Excel) and Windows operating systems.
• Demonstrated expertise in pharmaceutical manufacturing, particularly in aseptic processing (fill and finish) and adherence to cGMP standards.
• Strong ability to troubleshoot equipment issues and perform root cause analysis.
• Excellent communication and teamwork skills to collaborate across functions.
• Ability to apply mathematical concepts such as fractions, percentages, ratios, and proportions in practical settings.

Additional Preferences:

• Experience performing aseptic manipulations within Grade A isolators.
• Familiarity with industry systems such as ERP and inventory management platforms.
• Proven ability to train others and contribute to process improvements in a GMP environment.